School Reintegration After Pediatric Hematopoietic Stem Cell Transplant

Unspecified Complication of Bone Marrow Transplant Clinical Trial

Official title:

School Reintegration After Pediatric Hematopoietic Stem Cell Transplant: Experiences of Children, Parents, Teachers and Providers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02052570
• Other study ID #: Pro00047417
• Status: Withdrawn
• Phase: N/A
• First received: January 27, 2014
• Last updated: February 2, 2015
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a qualitative study that will explore the experiences of school reentry following Hematopoietic Stem Cell Transplant (HSCT) in children ages 10-16 years of age, their parents, teachers and primary PBMT(Pediatric Bone Marrow Transplant) providers. This study will involve four focus groups: children post -transplant, parents, teachers and PBMT providers in an effort to understand the successes and challenges of returning to school following HSCT.

Description:

This is a qualitative descriptive study using purposive sampling to form the four focus groups to encourage diversity in diagnosis (immunodeficiency, malignancy, bone marrow failure and inherited metabolic diseases), age and location. Each group will participate via conference call due to difference in location. There will be semi-structured questions for each group but also allow flexibility by participants themselves.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 16 Years

Eligibility

Inclusion Criteria:

• Children transplanted in the PBMT program at DUMC in the past 5 years for allogeneic HSCT to include diagnoses for malignancy, immunodeficiency, bone marrow failure and inherited metabolic disease. They must have previously attended school prior to transplant

Exclusion Criteria:

• Autologous transplants

• Significant developmental delays that would impair ability to communicate

• Inability to get full team (child, parent, teacher, provider) to participate

• Non-English speaking

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Unspecified Complication of Bone Marrow Transplant

Locations

Country	Name	City	State
United States	Duke University Health Systems	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychosocial issues	Psychosocial issues related to school reentry following pediatric hematopoietic stem cell transplant (HSCT) as gathered from children's, parent's, teacher's and health care provider's perspectives as obtained during focus group discussions.	90 minutes	No
Primary	Cultural and environmental issues	Cultural and environmental issues (ie location, resources) issues related to school reentry following pediatric hematopoietic stem cell transplant (HSCT) gathered from the children's, parent's, teacher's and health care provider's perspectives as obtained during focus group discussions.	90 minutes	No